Canon UDEX-i2
Device Model:
UDEX-i2
Manufacturer:
Canon Medical Systems Corporation, 1385 Shimoishigami, Otawara-shi, Tochigi 324-8550, JAPAN.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for use as a public facility
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Canon UDEX-i2 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for use as a public facility.
Assessment:
While the technology used in the Canon UDEX-i2, to measure blood pressure, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None While a clinical validation is claimed, it cannot be checked properly.
BP Japanese Society of Hypertension Professional use (2024) Unpublished validation